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40760

Beskrivning

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Nyckelord

Versioner (5)
  1. 2020-04-24 2020-04-24 -
  2. 2020-04-24 2020-04-24 -
  3. 2020-04-30 2020-04-30 -
  4. 2020-05-06 2020-05-06 -
  5. 2020-05-08 2020-05-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 maj 2020

DOI

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Creative Commons BY-NC 4.0
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    Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

    Engelsk

    Laboratory Collections; Urinalysis Test Results; Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

    1 Formulär  
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Beskrivning

    Centre Number

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Laboratory Collections - Clinical Chemistry & Haematology (Screening)
    Beskrivning

    Laboratory Collections - Clinical Chemistry & Haematology (Screening)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    UMLS CUI-3
    C0018941
    UMLS CUI-4
    C0220908
    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
    Beskrivning

    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0008000
    UMLS CUI [3]
    C0018941
    UMLS CUI [4,1]
    C0005834
    UMLS CUI [4,2]
    C0011008
    UMLS CUI [4,3]
    C0040223
    Laboratory Collections - Clinical Chemistry & Haematology - Comments
    Beskrivning

    Laboratory Collections - Clinical Chemistry & Haematology - Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0008000
    UMLS CUI [3]
    C0018941
    UMLS CUI [4]
    C0947611
    Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Beskrivning

    If YES, please record diagnosis on Baseline Signs and Symptom page.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0008000
    UMLS CUI [3]
    C0018941
    UMLS CUI [4,1]
    C1853129
    UMLS CUI [4,2]
    C2826293
    Laboratory Collections - Clinical Chemistry & Haematology (Follow-Up)
    Beskrivning

    Laboratory Collections - Clinical Chemistry & Haematology (Follow-Up)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    UMLS CUI-3
    C0018941
    UMLS CUI-4
    C1522577
    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
    Beskrivning

    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0008000
    UMLS CUI [3]
    C0018941
    UMLS CUI [4,1]
    C0005834
    UMLS CUI [4,2]
    C0011008
    UMLS CUI [4,3]
    C0040223
    Laboratory Collections - Clinical Chemistry & Haematology - Comments
    Beskrivning

    Laboratory Collections - Clinical Chemistry & Haematology - Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0008000
    UMLS CUI [3]
    C0018941
    UMLS CUI [4]
    C0947611
    Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at baseline?
    Beskrivning

    If YES, please record diagnosis on Adverse Event page.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0008000
    UMLS CUI [3]
    C0018941
    UMLS CUI [4,1]
    C1853129
    UMLS CUI [4,2]
    C2826293
    UMLS CUI [5]
    C1442488
    Laboratory Collections - Drug Screening (Urine)
    Beskrivning

    Laboratory Collections - Drug Screening (Urine)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0202274
    Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling
    Beskrivning

    Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0202274
    UMLS CUI [3,1]
    C0870078
    UMLS CUI [3,2]
    C0011008
    UMLS CUI [3,3]
    C0040223
    Were there any contra-indicated drugs detected?
    Beskrivning

    If YES, please record all the relevant contra-indicated drugs below.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C4036061
    UMLS CUI [1,3]
    C1301624
    Laboratory Collections - Drug Screening (Urine) - Type of drug
    Beskrivning

    Laboratory Collections - Drug Screening (Urine) - Type of drug

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0202274
    UMLS CUI [3]
    C0457591
    Laboratory Collections - Drug Screening (Urine) - Comment
    Beskrivning

    Laboratory Collections - Drug Screening (Urine) - Comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0022885
    UMLS CUI [2]
    C0202274
    UMLS CUI [3]
    C0947611
    Urinalysis Test Results (Screening)
    Beskrivning

    Urinalysis Test Results (Screening)

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0587081
    Urinalysis Test Results - Exact date and time of urine sampling
    Beskrivning

    Urinalysis Test Results - Exact date and time of urine sampling

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [2,1]
    C0200354
    UMLS CUI [2,2]
    C0011008
    UMLS CUI [2,3]
    C0040223
    Urinalysis Test Results - Comments
    Beskrivning

    Urinalysis Test Results - Comments

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [1,3]
    C0947611
    Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Beskrivning

    If YES, please record diagnosis on Baseline Signs and Symptom page.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [2,1]
    C1853129
    UMLS CUI [2,2]
    C2826293
    Urinalysis Test Results (Follow-Up)
    Beskrivning

    Urinalysis Test Results (Follow-Up)

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0587081
    Urinalysis Test Results - Exact date and time of urine sampling
    Beskrivning

    Urinalysis Test Results - Exact date and time of urine sampling

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [2,1]
    C0200354
    UMLS CUI [2,2]
    C0011008
    UMLS CUI [2,3]
    C0040223
    Urinalysis Test Results - Comments
    Beskrivning

    Urinalysis Test Results - Comments

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [1,3]
    C0947611
    Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at at baseline?
    Beskrivning

    If YES, please record diagnosis on Baseline Signs and Symptom page.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [2,1]
    C1853129
    UMLS CUI [2,2]
    C2826293
    UMLS CUI [3]
    C1442488
    Urinalysis Test Results - Results for dip stick test:
    Beskrivning

    Urinalysis Test Results - Results for dip stick test:

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0587081
    UMLS CUI-3
    C1160927
    Results for dip stick - Parameter
    Beskrivning

    Results for dip stick - Parameter

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1160927
    UMLS CUI [2]
    C0549193
    Result for dip stick test
    Beskrivning

    Result for dip stick test

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1160927
    UMLS CUI [1,2]
    C1274040
    Result for dip stick test - Clinically Significant
    Beskrivning

    Result for dip stick test - Clinically Significant

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1160927
    UMLS CUI [1,2]
    C2826293
    Result for dip stick test - Comments
    Beskrivning

    Result for dip stick test - Comments

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1160927
    UMLS CUI [1,2]
    C0947611
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies
    Beskrivning

    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

    Alias
    UMLS CUI-1
    C0019168
    UMLS CUI-2
    C0166049
    UMLS CUI-3
    C0019683
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling
    Beskrivning

    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C0019168
    UMLS CUI [2]
    C0166049
    UMLS CUI [3]
    C0019683
    UMLS CUI [4,1]
    C0005834
    UMLS CUI [4,2]
    C0011008
    UMLS CUI [4,3]
    C0040223
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments
    Beskrivning

    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0019168
    UMLS CUI [2]
    C0166049
    UMLS CUI [3]
    C0019683
    UMLS CUI [4]
    C0947611
    Hepatitis B Surface Antigen - Was the result positive?
    Beskrivning

    Hepatitis B Surface Antigen - Was the result positive?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019168
    UMLS CUI [2]
    C1514241
    Hepatitis C Antibodies - Was the result positive?
    Beskrivning

    Hepatitis C Antibodies - Was the result positive?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0166049
    UMLS CUI [2]
    C1514241
    HIVI/II Antibodies - Was the result positive?
    Beskrivning

    HIVI/II Antibodies - Was the result positive?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019683
    UMLS CUI [2]
    C1514241
    Tillbaka till toppen

    Similar models

    Laboratory Collections; Urinalysis Test Results; Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Laboratory Collections - Clinical Chemistry & Haematology (Screening)
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    C0018941 (UMLS CUI-3)
    C0220908 (UMLS CUI-4)
    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
    Item
    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
    datetime
    C0022885 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    C0018941 (UMLS CUI [3])
    C0005834 (UMLS CUI [4,1])
    C0011008 (UMLS CUI [4,2])
    C0040223 (UMLS CUI [4,3])
    Laboratory Collections - Clinical Chemistry & Haematology - Comments
    Item
    Laboratory Collections - Clinical Chemistry & Haematology - Comments
    text
    C0022885 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    C0018941 (UMLS CUI [3])
    C0947611 (UMLS CUI [4])
    Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Item
    Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    boolean
    C0022885 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    C0018941 (UMLS CUI [3])
    C1853129 (UMLS CUI [4,1])
    C2826293 (UMLS CUI [4,2])
    Item Group
    Laboratory Collections - Clinical Chemistry & Haematology (Follow-Up)
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    C0018941 (UMLS CUI-3)
    C1522577 (UMLS CUI-4)
    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
    Item
    Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
    datetime
    C0022885 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    C0018941 (UMLS CUI [3])
    C0005834 (UMLS CUI [4,1])
    C0011008 (UMLS CUI [4,2])
    C0040223 (UMLS CUI [4,3])
    Laboratory Collections - Clinical Chemistry & Haematology - Comments
    Item
    Laboratory Collections - Clinical Chemistry & Haematology - Comments
    text
    C0022885 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    C0018941 (UMLS CUI [3])
    C0947611 (UMLS CUI [4])
    Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at baseline?
    Item
    Laboratory Collections - Clinical Chemistry & Haematology - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at baseline?
    boolean
    C0022885 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    C0018941 (UMLS CUI [3])
    C1853129 (UMLS CUI [4,1])
    C2826293 (UMLS CUI [4,2])
    C1442488 (UMLS CUI [5])
    Item Group
    Laboratory Collections - Drug Screening (Urine)
    C0022885 (UMLS CUI-1)
    C0202274 (UMLS CUI-2)
    Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling
    Item
    Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling
    datetime
    C0022885 (UMLS CUI [1])
    C0202274 (UMLS CUI [2])
    C0870078 (UMLS CUI [3,1])
    C0011008 (UMLS CUI [3,2])
    C0040223 (UMLS CUI [3,3])
    Were there any contra-indicated drugs detected?
    Item
    Were there any contra-indicated drugs detected?
    boolean
    C1511790 (UMLS CUI [1,1])
    C4036061 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [1,3])
    Laboratory Collections - Drug Screening (Urine) - Type of drug
    Item
    Laboratory Collections - Drug Screening (Urine) - Type of drug
    text
    C0022885 (UMLS CUI [1])
    C0202274 (UMLS CUI [2])
    C0457591 (UMLS CUI [3])
    Laboratory Collections - Drug Screening (Urine) - Comment
    Item
    Laboratory Collections - Drug Screening (Urine) - Comment
    text
    C0022885 (UMLS CUI [1])
    C0202274 (UMLS CUI [2])
    C0947611 (UMLS CUI [3])
    Item Group
    Urinalysis Test Results (Screening)
    C0042014 (UMLS CUI-1)
    C0587081 (UMLS CUI-2)
    Urinalysis Test Results - Exact date and time of urine sampling
    Item
    Urinalysis Test Results - Exact date and time of urine sampling
    datetime
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C0200354 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Urinalysis Test Results - Comments
    Item
    Urinalysis Test Results - Comments
    text
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Item
    Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    boolean
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C1853129 (UMLS CUI [2,1])
    C2826293 (UMLS CUI [2,2])
    Item Group
    Urinalysis Test Results (Follow-Up)
    C0042014 (UMLS CUI-1)
    C0587081 (UMLS CUI-2)
    Urinalysis Test Results - Exact date and time of urine sampling
    Item
    Urinalysis Test Results - Exact date and time of urine sampling
    datetime
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C0200354 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Urinalysis Test Results - Comments
    Item
    Urinalysis Test Results - Comments
    text
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at at baseline?
    Item
    Urinalysis Test Results - Are there CLINICALLY SIGNIFICANT ABNORMAL values not present at at baseline?
    boolean
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C1853129 (UMLS CUI [2,1])
    C2826293 (UMLS CUI [2,2])
    C1442488 (UMLS CUI [3])
    Item Group
    Urinalysis Test Results - Results for dip stick test:
    C0042014 (UMLS CUI-1)
    C0587081 (UMLS CUI-2)
    C1160927 (UMLS CUI-3)
    Item
    Results for dip stick - Parameter
    integer
    C1160927 (UMLS CUI [1])
    C0549193 (UMLS CUI [2])
    Parameter
    Code List
    Results for dip stick - Parameter
    CL Item
    PH (1)
    CL Item
    Protein (2)
    CL Item
    Glucose (3)
    CL Item
    Biliribin (4)
    CL Item
    Blood (5)
    Result for dip stick test
    Item
    Result for dip stick test
    text
    C1160927 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result for dip stick test - Clinically Significant
    Item
    Result for dip stick test - Clinically Significant
    boolean
    C1160927 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Result for dip stick test - Comments
    Item
    Result for dip stick test - Comments
    text
    C1160927 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies
    C0019168 (UMLS CUI-1)
    C0166049 (UMLS CUI-2)
    C0019683 (UMLS CUI-3)
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling
    Item
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling
    datetime
    C0019168 (UMLS CUI [1])
    C0166049 (UMLS CUI [2])
    C0019683 (UMLS CUI [3])
    C0005834 (UMLS CUI [4,1])
    C0011008 (UMLS CUI [4,2])
    C0040223 (UMLS CUI [4,3])
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments
    Item
    Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments
    text
    C0019168 (UMLS CUI [1])
    C0166049 (UMLS CUI [2])
    C0019683 (UMLS CUI [3])
    C0947611 (UMLS CUI [4])
    Hepatitis B Surface Antigen - Was the result positive?
    Item
    Hepatitis B Surface Antigen - Was the result positive?
    boolean
    C0019168 (UMLS CUI [1])
    C1514241 (UMLS CUI [2])
    Hepatitis C Antibodies - Was the result positive?
    Item
    Hepatitis C Antibodies - Was the result positive?
    boolean
    C0166049 (UMLS CUI [1])
    C1514241 (UMLS CUI [2])
    HIVI/II Antibodies - Was the result positive?
    Item
    HIVI/II Antibodies - Was the result positive?
    boolean
    C0019683 (UMLS CUI [1])
    C1514241 (UMLS CUI [2])
    Tillbaka till toppen 

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